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Clinical research studies (also known as clinical trials) are designed to help answer specific health questions. For example, whether an investigational drug is an effective option to treat an illness or whether it has any undesirable side effects.

Investigational drugs go through several phases of clinical research to determine the potential drug’s safety and effectiveness.

These phases are often described as:

  • Phase I: The investigational drug is given to a few individuals to evaluate its safety. Often to healthy volunteers.
  • Phase II: The investigational drug is given to an increased number of individuals with the disease of interest. The goal of this phase is to evaluate both effectiveness and safety, The researchers also investigate which dose is appropriate.
  • Phase III: In the final stage of development, the investigational drug is given to many individuals with the disease. Phase III studies are often pivotal, meaning they are meant to confirm if the investigational drug is effective and safe. DIAGNODE-3 is a phase III clinical trial.
There are many reasons why one may want to participate in a clinical trial:
  • A chance to gain access to an investigational drug when there are no available treatments
  • Contribute to finding potential effective treatments for future patients
  • Access to a medical team that can provide additional education and close monitoring

Before a clinical trial is allowed to start, doctors, scientists and others working at government agencies review the intended study to see that participants’ safety and rights are respected. Before any study procedures or assessments are done, the patient needs to go through the informed consent process.

The doctor will describe and discuss the investigational drug, study procedures and the patient’s rights with the patient and if applicable, their legal guardian/parent. You can ask any question you want to your doctor. Throughout the clinical trial, the patient is monitored closely by the study team through regular visits and phone calls.

Individuals who participate have the right to:

  • Ask any questions about the study
  • Take as much time as they want before deciding whether to participate
  • Leave the study at any time for any reason